With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s …
As was introduced in our recent blog post summarizing the 2022 MedTech conference (here), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot (see announcement attributed …
In our last blog post, we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program. User Fees User …
On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”). In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several …
At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF) The IMDRF conference was …
FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). We have followed it over the last five years, with blog posts here, here, here, …
On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance …
If you have purchased anything in recent months or kept up with economic reports, you are familiar with the unwelcome observation: “Prices have gone up!” That could not be more true than in the area of medical device user fees. Medical Device User Fees After the Congressional …
Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here). Amongst CDRH’s highest prioritized …
“We still have a problem with COVID. We’re still doing a lot of work on it. But the pandemic is over. If you notice, no one is wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.” President Biden made …
On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains …
It is with great excitement that we share CDRH’s announcement that now anyone may submit premarket submissions directly to the Center through the Customer Collaboration Portal (CCP). We heard from a number of readers after our prior post (here) asking how they could get access …
Nearly one year after FDA published a draft guidance on its Electronic Submission Template for Medical Device Submissions (see our blog post here), the Agency is back to formally introduce the widespread implementation of the electronic Submission Template And Resource (eSTAR) electronic submission template for …
Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. Allegations may include failure to register and list a medical device, promotion of a device outside the scope of its …
On September 28, 2022, FDA published its long-awaited final guidance document entitled “Clinical Decision Support Software,” which interprets the medical software provisions of the 21st Century Cures Act (Cures Act). The final guidance was preceded by two iterations of draft guidance—one in 2017 and one in …
